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Rethinking Lower Blood Pressure Goals for Diabetic Patients with Coronary Artery Disease – Findings from the INternational VErapamil SR – Trandolapril STudy (INVEST)
Rethinking Lower Blood Pressure Goals for Diabetic Patients with Coronary Artery Disease – Findings from the INternational VErapamil SR – Trandolapril STudy (INVEST)
Rhonda M. Cooper-DeHoff, Yan Gong, Eileen M. Handberg, Anthony A. Bavry, Scott J. Denardo, George L. Bakris and
Carl J. Pepine
on behalf of the INVEST Investigators
University of Florida
Gainesville, FL
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DisclosuresDisclosures
• INVEST conduct and analysis was funded by Abbott Laboratories through 12/2008
• Cooper-DeHoff: research grant NHLBI (K23HL086558)
• Handberg: unrestricted educational grants AstraZeneca, AtCor Medical, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi-Aventis, and Schering-Plough
• Bakris: research grants Juvenile Diabetes Research Foundation, Glaxo Smith Kline, Forest Laboratories and CVRx; consultant Glaxo Smith Kline, Merck, Novartis, Boehringer-Ingelheim, Takeda, Abbott Laboratories, Walgreen’s, Bristol Meyer Squibb/Sanofi, Gilead, Forest Labs and CVRx.
• Pepine: research grants NHLBI, Baxter, Pfizer, GlaxoSmithKline, and Bioheart, Inc; consultant Abbott Laboratories, Forest Labs, Novartis/Cleveland Clinic, NicOx, Angioblast, Sanofi-Aventis, NIH, Medtelligence, and SLACK Inc; unrestricted educational grants AstraZeneca, AtCor Medical, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi-Aventis, and Schering-Plough.
• Gong, Bavry and Denardo: None
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BackgroundBackground
Diabetes Care. 2010;33 Suppl 1:S11-61, Hypertension. 2003;42(6):1206-1252, Diabetes Care. 2002;25(1):199-201
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ObjectiveObjective
To determine the effect of level of SBP reduction on adverse CV outcomes in a cohort of patients with diabetes and CAD
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HypothesisHypothesis
Diabetic patients who achieved SBP <130 mm Hg would have reduced CV outcomes compared with diabetic patients who achieved SBP ≥130-<140 mm Hg
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INVEST Trial DesignINVEST Trial Design
Pepine et al. JAMA. 2003:290:2805-2816
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MethodsMethods
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Results: Flow DiagramResults: Flow Diagram
INVEST22,576
(17,131 US)
Diabetes6,400
(5,077 US)
Tight Control
2,255 (35%)
Usual Control
1,970 (31%)
Not Controlled
2,175 (34%)
INVEST Follow Up16,893 pt years
Extended Follow Up22,700 pt years
Alive2,010
Dead248
Alive1,769
Dead201
Alive1,841
Dead334
Alive, US
1,558 Alive1,188
Dead370
Alive, US
1,423
Dead259
Alive1,164
Alive, US
1,389
Dead270
Alive1,119
39,593 pt yrs
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Results: Baseline CharacteristicsResults: Baseline CharacteristicsTight Control
n=2,255Usual Control
n=1,970Not Controlled
n=2,175
Mean age (yr) (SD) 65 (9) 66 (9) 67 (9)
Age > 70 yr (%) 29 32 36
Mean BMI (kg/m2) (SD) 30 (6) 31 (6) 31 (6)
Beta Blocker Strategy (%) 49 49 52
Women (%) 51 54 59
Race/Ethnicity (%) Caucasian Non-Caucasian
4159
4654
4654
Chronic Angina (%) 72 66 65
Prior MI (%) 36 33 34
Prior Stroke/TIA (%) 8.4 8.5 11
Smoking History (%) 49 45 44
Renal Impairment (%) 3.6 2.4 5.0
Hypercholesterolemia 64 62 61
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Results – BP ReductionResults – BP Reduction
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Results – Antihypertensive Drug UseResults – Antihypertensive Drug Use
0%
20%
40%
60%
80%
100%
Tight Control Usual Control Not Controlled
0 1 2 3 or more
Mean Number of Study + Nonstudy Antihypertenisve Drugs
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Results: Outcome Rates Results: Outcome Rates
INVEST Follow Upn=6400
Tight Controln=2,255
Usual Control n=1,970
Not Controlled
n=2,175
p value
Outcome # of Events (Event Rate %)
Primary Outcome 286 (12.7) 249 (12.6) 431 (19.8) < 0.0001
Nonfatal MI 29 (1.3) 33 (1.7) 67 (3.1) 0.008
Nonfatal Stroke 22 (1.0) 26 (1.3) 52 (2.4) 0.001
Total MI 108 (4.8) 100 (5.0) 185 (8.5) < 0.0001
Total Stroke 34 (1.5) 33 (1.7) 70 (3.2) 0.0001
All Cause Mortality 248 (11.0) 201 (10.2) 334 (15.4) < 0.0001
Extended Follow Upn=4370
Tight Controln=1,389
Usual Control n=1,423
Not Controlled
n=1,558
p value
Outcome # of Events (Event Rate %)
All Cause Mortality 270 (19.4) 259 (18.2) 370 (23.7) 0.01
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Results: Outcomes During INVEST Results: Outcomes During INVEST
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0 2 4 6 8 10 12
Results: Outcomes – US CohortResults: Outcomes – US Cohort
Adj. HR 1.15, 95% CI 1.01-1.32, p=0.036
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(n=2,255)
Reference
Results: Outcomes – Tight Control GroupResults: Outcomes – Tight Control Group
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LimitationsLimitations
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SummarySummary
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ConclusionConclusion
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Mortality – DBP US DiabeticsMortality – DBP US Diabetics
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Mortality – Tight DBP GroupMortality – Tight DBP Group
Reference
Diastolic Blood Pressure (mm Hg)